Roux-en-Y Hepaticojejunostomy for Hepatolithiasis With Sphincter of Oddi Laxity

NCT01459549 | Completed

• 1 other identifier: ZYYYSOL
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Evaluate the role of Roux-en-Y hepaticojejunostomy (RYHJ) in hepatolithiasis patients with sphincter of Oddi laxity (SOL). Summary Background Data: Hepatolithiasis poses high risks of residual, recurrence, and re-intervention. SOL significantly impacts this condition. RYHJ has been recommended for hepatolithiasis concomitant SOL but without prospective evidence. Methods: This is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent SOL. Patients were randomly assigned (1:1) to undergo RYHJ or not. The primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. Secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. The analyses followed the intention-to-treat principle.

Conditions

Hepatolithiasis; Sphincter of Oddi Dysfunction

Keywords

Hepatolithiasis; Sphincter of Oddi Dysfunction; Roux-en-Y hepaticojejunostomy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The incidence of stones, including residual and recurrent stones, within three years postoperatively.

  The term "stone occurrence" pertained to the identification of any bile duct stones with the most reliable imaging modality available during the follow-up period. "Stone residual" described a patient in whom stones were detected during the initial follow-up examination, while "stone recurrence" referred to a patient who exhibited no stones at the first follow-up visit but subsequently presented with stones during later follow-up assessments.

  A three-year postoperative period

Secondary Outcomes (6)

• Major complications

  perioperation

• Episodes of cholangitis

  3-year follow-up period

• Invasive re-interventions for stones and related complications

  3-year follow-up period

• Postoperative hospital stays

  perioperation

• Medical expenses

  perioperation

Other Outcomes (1)

• Cholangiocarcinoma arising

  3-year follow-up period

Study Arms (2)

Control arm

NO INTERVENTION

The common bile duct will be maintained for bile drainage in the control arm.

Trial arm

EXPERIMENTAL

Roux-en-Y hepaticojejunostomy will be performed for bile drainage in the trial arm.

Procedure: Roux-en-Y hepaticojejunostomy

Interventions

Roux-en-Y hepaticojejunostomy PROCEDURE

All participants received routine perioperative care and followed the same surgical principles: removing affected liver segments, clearing stones, correcting strictures, and then restoring bile drainage. The primary indications for hepatectomy were unilobar or segmental diseases and the presence of the following lesions in the affected liver segment or lobe: 1) multiple stones with biliary strictures that cannot be cured via choledochoscopy, 2) atrophy, fibrosis, and multiple abscesses, and 3) suspicious neoplasia. Biliary exploration was routinely conducted to facilitate stone removal, rectify strictures, and assess the functionality of the Oddi sphincter. Following this, patients would be evaluated for eligibility and assigned accordingly. The sole distinction between the two arms was performing RYHJ or maintaining the common bile duct for bile drainage.

Trial arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 80 years
• diagnosed with SOL during operation
• suitable for a radical surgery including RYHJ
• hopeful to clear stones via operation or combined with subsequent choledochoscopy
• provided written informed consent
• willing to complete a 3-year follow-up
• An intraoperative diagnosis of SOL was established if the rhythmic contraction and relaxation of the sphincter of Oddi were not observed under choledochoscope and the flexible choledochoscope (CHF-P20, external diameter, 4.9 mm; Olympus, Tokyo, Japan) could navigate smoothly to the duodenum through the sphincter of Oddi without any pre-dilation interventions.

You may not qualify if:

• with imaging evidences of tumor preoperatively
• had congenital biliary malformations
• had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction

Condition Hierarchy (Ancestors)

Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: December 13, 2010
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CN (1)